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MAPK Pathway Inhibitor
DCC-3116 for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Deciphera Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants enrolled in the DCC-3116 and sotorasib cohort (Cohort D) must have a KRAS G12C mutation.
Have not received prior MEK inhibitor therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, DCC-3116, as a possible treatment for advanced or metastatic solid tumors. The study will consist of two parts: a dose-escalation phase, where patients will receive increasing doses of the drug to test its safety, and an expansion phase, where patients will receive the drug in combination with other drugs to test its effectiveness.
Who is the study for?
Adults with advanced solid tumors having specific mutations (RAS/MAPK pathway) who've had certain prior treatments can join. They need good organ function, an ECOG score of 0-2, and must not be pregnant or breastfeeding. Contraception is required for both men and women.Check my eligibility
What is being tested?
The trial tests DCC-3116 alone or with trametinib, binimetinib, or sotorasib in two phases: dose escalation to find safe amounts and expansion to see effects on different cancers like colorectal cancer and melanoma.See study design
What are the potential side effects?
Potential side effects include typical reactions from targeted cancer therapies such as fatigue, digestive issues, skin rash, liver enzyme changes. Specific side effect profiles will depend on the drug combination received.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a KRAS G12C mutation.
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I have never been treated with MEK inhibitors.
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My lung cancer has a specific KRAS G12C mutation.
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My pancreatic cancer has a KRAS mutation.
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I've had 1 or 2 treatments for advanced cancer that included drugs to boost my immune system.
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My lung cancer has a specific genetic mutation.
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I have a BRAF V600 mutation and have tried treatments that are known to work.
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I have had 1 to 3 treatments for my advanced cancer.
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I am mostly active and can care for myself.
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My advanced cancer has a confirmed RAS, NF1, or RAF mutation.
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I have had at least 2 treatments for my advanced cancer.
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My melanoma has an NRAS mutation.
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My colorectal cancer has a specific genetic mutation.
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I have had 2 to 4 treatments for my advanced cancer.
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I am 18 years old or older.
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I have had one treatment for my cancer after it spread.
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My NSCLC has a KRAS G12C mutation.
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I have been diagnosed with Pancreatic Ductal Adenocarcinoma.
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My cancer has worsened despite treatment, and I've had at least one type of cancer therapy.
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I have never been treated with sotorasib or similar drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Maximum tolerated dose (MTD)
Objective response rate (ORR) (Expansion Phase)
Secondary outcome measures
Area under the concentration-time curve( AUC)
Disease Control Rate (DCR) (Escalation Phase)
Duration of response (DoR) (Escalation Phase)
+5 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Expansion Cohort 5 (Part 2)Experimental Treatment2 Interventions
DCC-3116 tablets orally given in combination with sotorasib in 28-day cycles to evaluate safety and preliminary efficacy of participants with NSCLC (with a documented mutation in KRAS G12C).
Group II: Expansion Cohort 4 (Part 2)Experimental Treatment3 Interventions
DCC-3116 tablets orally given in combination with binimetinib in 28-day cycles to evaluate safety and preliminary efficacy of participants with melanoma (with a documented mutation in NRAS).
Group III: Expansion Cohort 3 (Part 2)Experimental Treatment2 Interventions
DCC-3116 tablets orally given in combination with trametinib in 28-day cycles to evaluate safety and preliminary efficacy of participants with colorectal cancer (CRC) (with a documented mutation in KRAS, NRAS, NF1, or BRAF).
Group IV: Expansion Cohort 2 (Part 2)Experimental Treatment2 Interventions
DCC-3116 tablets orally given in combination with trametinib in 28-day cycles to evaluate safety and preliminary efficacy of participants with non-small cell lung cancer (NSCLC) (with a documented mutation in KRAS, NRAS, NF1,or BRAF).
Group V: Expansion Cohort 1 (Part 2)Experimental Treatment2 Interventions
DCC-3116 tablets given in combination with trametinib in 28-day cycles to evaluate safety and preliminary efficacy of participants with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) (with a documented mutation in KRAS).
Group VI: Dose Escalation (Part 1, Cohort D Combination)Experimental Treatment2 Interventions
Upon determination of the RP2D/MTD single agent, DCC-3116 will be dosed in combination with sotorasib.
Group VII: Dose Escalation (Part 1, Cohort C Combination)Experimental Treatment2 Interventions
Upon determination of the RP2D/MTD single agent, DCC-3116 will be dosed in combination with binimetinib.
Group VIII: Dose Escalation (Part 1, Cohort B Combination)Experimental Treatment2 Interventions
Upon determination of the RP2D/MTD single agent, DCC-3116 will be dosed in combination with trametinib.
Group IX: Dose Escalation (Part 1, Cohort A Monotherapy)Experimental Treatment1 Intervention
DCC-3116 tablets in escalating dose cohorts given orally twice daily (BID) in 28-day cycles as monotherapy (single agent). If no DLT in 3 participants or 1 DLT/6 participants is observed, dose escalation may continue to the next planned dose cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Binimetinib
FDA approved
Sotorasib
FDA approved
Find a Location
Who is running the clinical trial?
Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
1,921 Total Patients Enrolled
Clinical TeamStudy DirectorDeciphera Pharmaceuticals LLC
2 Previous Clinical Trials
224 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a KRAS G12C mutation.I haven't taken any experimental drugs with unknown safety for at least 28 days, or 14 days with approval.I stopped taking trametinib or binimetinib due to side effects.I can provide a new or old sample of my tumor for the study.I stopped taking sotorasib because of its side effects.I haven't taken any strong medication or certain herbal remedies that affect liver enzymes in the last 14 days or more.I am receiving or have received treatment for bone disease.I agree to follow the required contraception methods.I have had blood clots in my arteries.I am on a stable HIV medication regimen with a viral load under 400 copies/mL.You have any other important health conditions that may affect your participation in the study.I have never been treated with MEK inhibitors.I am in the dose expansion phase of the trial.I have not had major surgery in the last 4 weeks and my surgical wounds are healed.My heart's electrical activity test shows prolonged QT intervals.My lung cancer has a specific KRAS G12C mutation.My pancreatic cancer has a KRAS mutation.I do not have severe heart problems or recent heart attacks.I've had 1 or 2 treatments for advanced cancer that included drugs to boost my immune system.I can stop taking acid reflux drugs 3 days before starting the study medication.My lung cancer has a specific genetic mutation.I haven't taken any cancer or investigational drugs for at least 14 days.I am not pregnant or breastfeeding.I have a BRAF V600 mutation and have tried treatments that are known to work.I have had 1 to 3 treatments for my advanced cancer.I am mostly active and can care for myself.My advanced cancer has a confirmed RAS, NF1, or RAF mutation.I have had at least 2 treatments for my advanced cancer.My melanoma has an NRAS mutation.I still have side effects from my previous cancer treatment.I have Non-Small Cell Lung Cancer.I have had blood clots in my veins.I have a condition that prevents my body from absorbing nutrients properly.I do not have active hepatitis B or C, and I am not on any prohibited medications.My colorectal cancer has a specific genetic mutation.I have had 2 to 4 treatments for my advanced cancer.I am 18 years old or older.I have had one treatment for my cancer after it spread.I am participating in the first part of the study, focusing on finding the right dose.I have colorectal cancer.My organs and bone marrow are working well.I have melanoma.My NSCLC has a KRAS G12C mutation.I have been diagnosed with Pancreatic Ductal Adenocarcinoma.You need to avoid eating grapefruit or drinking grapefruit juice for 14 days.I have brain metastases or leptomeningeal disease but they are stable.I haven't had any AIDS-related infections in the past year.My cancer has worsened despite treatment, and I've had at least one type of cancer therapy.I have never been treated with sotorasib or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Cohort 5 (Part 2)
- Group 2: Dose Escalation (Part 1, Cohort C Combination)
- Group 3: Expansion Cohort 2 (Part 2)
- Group 4: Expansion Cohort 4 (Part 2)
- Group 5: Expansion Cohort 1 (Part 2)
- Group 6: Expansion Cohort 3 (Part 2)
- Group 7: Dose Escalation (Part 1, Cohort D Combination)
- Group 8: Dose Escalation (Part 1, Cohort A Monotherapy)
- Group 9: Dose Escalation (Part 1, Cohort B Combination)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities available to join this research endeavor?
"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is currently underway; it was initially posted on June 15th 2021 and most recently edited on May 25th 2022. The trial requires the enrollment of 323 patients at 5 distinct sites."
Answered by AI
Are there various sites conducting this trial within the state's boundaries?
"This research is recruiting from 5 different sites, located in Austin, Philadelphia and Houston as well as 2 other locations. To lessen the burden of travel for potential participants, it's advisable to pick a trial site nearby."
Answered by AI
What other research initiatives have been explored utilizing DCC-3116?
"First evaluated at the University of Chicago Medical Centre in 2012, DCC-3116 has since undergone 78 tests. Presently, there are 92 trials recruiting patients with a notable concentration of sites functioning out of Austin, Texas."
Answered by AI
What specific aims does this research endeavor intend to accomplish?
"The purpose of this medical trial, which will span a 24-month period, is to assess the objective response rate (ORR). Other key metrics that will be observed include time to response (TTR), disease control rate (DCR) and duration of response (DoR). TTR is measured from treatment commencement until initial assessment demonstrating complete or partial remission. DCR indicates the portion of partakers who experience full/partial remission or stable illness at a definable point in time. DoR describes how long results last after first achieving either complete or partial remittance up till progression or death takes place."
Answered by AI
How many participants have enrolled in this research endeavor?
"In order to successfully complete this clinical trial with the desired results, 323 individuals fitting the specified criteria will be required. Interested patients may join from either NEXT Oncology in Austin or Hospital of the University of Pennsylvania in Philadelphia."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
NEXT Oncology
The University of Texas MD Anderson Cancer Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
Hoping for effective treatment before tumor metastases.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 1 Day
Most responsive sites:
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health: < 24 hours
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